Applying regulatory flexibility in the age of COVID-19

Jenny Sharpe

Senior Scientific Writer, CIRS

Clarivate

Share this article

A study by the Centre for Innovation in Regulatory Science has found that there are numerous regulatory routes that can be used to assess and authorise medical products during a public health emergency or pandemic. Although yet to be used extensively, these Emergency Use Pathways (EUPs) offer the regulatory flexibility needed to ensure that medical products can be developed, fairly assessed and ultimately made available to patients during a time of crisis.

Characteristics of emergency use pathways

The aim of the study was to provide a high-level overview of EUPs made available by seven major regulatory authorities (United States, Europe, Australia, Canada, Switzerland, Japan and China) and the World Health Organisation (WHO). The authors reviewed EUPs for marketing authorisations of vaccines or therapeutics, rather than emergency pathways for authorising clinical trials.

The analysis showed that a diverse and flexible group of EUPs are available in the seven mature jurisdictions studied. While some EUPs have been created specifically for COVID-19, others are established pathways that are used routinely in non-pandemic situations. Examples include compassionate use, specific government mandates, as well as an agency’s usual pathways for medicines of high unmet need.

Several of the identified EUPs allow exemptions from the usual regulatory requirements, with the risk being managed by requiring alignment with specific standards, guidance and strict medical oversight. Other possible advantages include more agency-sponsor interactions pre-submission and the option for rolling submission, which allows sections of the application to be considered for review as they are completed.

Applicability of EUPs in Low- and Middle-Income Countries (LMICs)

The authors also investigated tools provided by the WHO to facilitate registration of medicines and vaccines globally. These tools not only include EUPs but also regulatory strengthening programmes that help to build capacity within regulatory agencies in LMICs and support them to make their own regulatory decisions. An example is a reliance mechanism on a regulatory decision, where the initial review is conducted by another competent regulatory agency and the LMIC agency uses that decision to more rapidly inform their local decision. Ultimately, a reliance approach helps to reduce the workload for the agency while still allowing an independent decision-making process. These considerations are important for LMICs where regulatory systems may not be able to address the immediate needs posed by pandemics.

Knowledge sharing in the age of COVID-19

While this toolbox of EUPs has not been used extensively in the current pandemic, as many of the therapeutics and vaccines are still in development, the authors found evidence of convergence and information sharing between regulators to help support a coordinated global approach to COVID-19. In the development space, a number of companies working on COVID-19 vaccines have come together through the WHO, committing to share data and strengthen cooperation in order to avoid duplication and improve efficiencies. The WHO and partners have also instigated the “Solidarity” trial, which is an international trial to help find an effective treatment for COVID-19.

An open-door policy for COVID-19

Within regulatory agencies such as EMA, the authors found that an “open-door policy” has been enacted for COVID-19 therapeutics explicitly addressing:

informal acceptance of submissions to be either assessed by the Committee for Medicinal Products for Human Use or forwarded to the EMA Pandemic Task Force or Scientific Advice Working Party, as appropriate;

early rapporteur assignment; and

the opportunity to benefit from rolling submissions.

However, such regulatory flexibility is not typically found in LMICs, so use of the WHO EUPs will be critical to enable these countries to have access to new vaccines and other quality, safe and effective countermeasures for COVID-19.

EUPs are ready to be used

This review demonstrates that EUPs are in place and ready to be used for the registration of pandemic-related therapies but need to be fully tested and refined. Implementing learning from the use of EUPs by well-resourced countries and LMICs, will be up to the WHO, society, scientists, epidemiologists and governments to put investment in long-term strategies, so that when the next pandemic occurs, the processes and procedures are in place to prevent delays in responding appropriately.